Medical device company St. Jude Medical Inc. (STJ) Friday announced the first patient implant in a new trial evaluating the company's AMPLATZER Cardiac Plug or ACP for the prevention of stroke. The company said the AMPLATZER Cardiac Plug Clinical Trial is designed to determine the safety and effectiveness of the ACP device in preventing blood clots from migrating out of the left atrial appendage in patients with non-valvular atrial fibrillation who have a high risk for stroke.
The implant was performed by Dr. Christian Machado, director of electrophysiology at the Providence Hospital Heart Institute, Southfield, Michigan, and investigator in the study.
Explaining the need for the trial, Dr. James Hermiller, an interventional cardiologist from St. Vincent Hospital in Indianapolis and ACP Trial investigator said, "The current standard of care for the prevention of stroke is warfarin or other oral blood-thinning medications that can be difficult for some people to tolerate, and may carry a risk of serious complications, such as bleeding.."
Commenting on the development, Frank Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division said, "The AMPLATZER Cardiac Plug has shown great promise in international markets and we look forward to establishing the evidence required to make it available in the U.S."
by RTT Staff Writer
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